Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
The revised user fees will go into effect October 1, 2016 and remain in effect through the end of September 2017. It is important to note that not all fees will be reduced, and some will increase. Following is an excerpt of the story, recently published in Regulatory Focus describing key changes: ANDA ($70,480, down…
Issued on August 8, 2016, regulatory impact includes the following: FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language This draft guidance preserves the basic format and content of the original, with updates to…
In case you need a regulatory refresher, the Request for Designation is the formal process to determine which Center will conduct premarket review and regulate a combination product (See Guidance for Industry Office of Combination Products April 2011: How to Write a Request for Designation). Recently, FDA announced through FDAVoice that changes to the program…
FDA recently approved another Rx-to-OTC switch. Formerly available by prescription only, Veramyst® will now be known for the purpose of OTC marketing as Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray). Sensimist™ (NDA 022051/S-013) is approved to treat symptoms associated with seasonal and perennial allergies. Read the full story here. The path to the…
FDA recently announced on FDAVoice that they plan to facilitate ways to encourage industry to submit an NDA for an Rx-to-OTC switch. The announcement directly addresses prescription naloxone, indicated for treatment of opioid overdose. This unusual step is consistent with FDA’s opioid action plan and is aimed at making the drug more widely available. To…
First approved in 1996, FDA recently approved a supplemental NDA (20380/S-010) for Differin® Gel (adapalene), 0.1% to be marketed as a nonprescription product in 2, 15, and 45 gram containers. In the approval letter, FDA noted that “usage and exposure were key review issues in our evaluation of the potential risks of nonprescription marketing. Research…
According to FDA, Consumers should “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” Click here for the full story or here to learn more about OTC drug development.
On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using Changes Being Effected (CBE) supplements (among other changes). In response, on November 13, 2013, FDA issued notice of a proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”…